The Role In this role, you will be responsible for supporting Process Engineering team members in the operability and reliability of cGMP manufacturing process equipment located at the Moderna manufacturing facility in Marlborough, MA. Applicants should enjoy working in a fast-paced, dynamic, and innovative environment. Here's What You’ll Do Assist the Process Engineering team to ensure the process operations and process equipment meet safety, compliance, and business requirements on a day-to-day basis. Assist the Process Engineering team to troubleshoot equipment to determine root cause of failure modes, implement Corrective/Preventative Actions and any associated change controls, and provide input on preventative maintenance plans. Assist the Process Engineering team with continuous improvement efforts. Help to provide engineering support for process equipment procurement and start-up at Moderna’s Marlborough manufacturing facility (Incubators, Centrifuges, Ultrafiltration, Chromatography, Tangential Flow Filtration, Robotic Filling Lines, Visual Inspection Machines, Automated Label/Pack Lines, Buffer Prep Vessels, Utility Support Systems, etc.). Participate on project teams throughout all phases of engineering projects related to process equipment, including development of user requirements, conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification. Review design documentation from conceptual through detailed design, including Engineering Turnover Packages, specifications, component lists, operating manuals, and drawings for cGMP process and utility equipment. Collaborate with cross functional team members across multiple disciplines such as Environmental Health & Safety, Facilities, Metrology, Digital Automation, Material Science & Technology, Manufacturing, and Quality. Follow all relevant GxP regulations, SOPs, guidelines, and company policies to ensure compliance with regulatory and internal requirements. Ability and willingness to complete cleanroom gowning training and occasionally enter and observe manufacturing operations in a classified cleanroom environment.
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Job Type
Full-time
Career Level
Intern